Description: In contrast to the IVDD, the IVDR’s conformity assessment of programmable electronic systems (devices that incorporate software systems or software that is a device in itself) is disproportionally more demanding. Based on the IVDR requirements, TÜV SÜD expert Dr. Alexander Stock will explain why cybersecurity is critical when designing, developing, and upgrading IVD medical devices across their life cycle. You will also learn why high-quality test evidence is essential to a successful Notified Body conformity assessment in this context.
Learning Objectives:
What are the main challenges regarding a IVDR software TD submission?
Why is high-quality test evidence essential for regulatory compliance?
Explain why cybersecurity is also crucial for in vitro diagnostic medical devices.
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